Primary Open Angle GlaucomaPhase 2NCT06223048
A Study of AMDX-2011P in Participants With Primary Open Angle Glaucoma
A Phase 2 study testing AMDX-2011P in people with Primary Open Angle Glaucoma, run by Amydis Inc. at 3 sites in United States.
Trial summary
The purpose of this research study is to assess the ability of AMDX- 2011P to identify amyloid deposits in the retina of participants with Primary Open Angle Glaucoma (POAG). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- AMDX-2011P
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Dec 2023to Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary open angle glaucoma in both eyes
- Able to fixate
- Glaucomatous optic nerve damage in both eyes, as determined by an investigator as part of an eye exam
Who cannot join
- Participants unable to read or write
- Ocular media is not sufficiently clear to obtain acceptable quality images
- Participants with presence of any ocular pathology other than glaucoma in the study eye (cataracts are acceptable)
Trial locations and contacts
3 sites in 1 country.
David Bingaman contact
United States3 sites, 3 recruiting
- Recruiting
Global Research Management
Glendale, California, 91204
Logi El-Harazi, logi@grmclinical.com
- Recruiting
Eye Research Foundation
Newport Beach, California, 92663
Linda Wirta, linda.wirta@drwirta.com
- Recruiting
Associated Retina Consultants
Phoenix, Arizona, 85020
Mallory Mintert, mallory.mintert@doctrials.com
About this study
Official title: A Phase 2, Randomized, Open Label Study of AMDX-2011P as a Retinal Tracer in Participants With Primary Open Angle Glaucoma
The purpose of this research study is to assess the ability of AMDX- 2011P to identify amyloid deposits in the retina of participants with Primary Open Angle Glaucoma (POAG).
Read the detailed description
This open-label, masked endpoint assessment study will evaluate safety, tolerability, plasma pharmacokinetics (PK) and biological activity of intravenous (IV) doses of AMDX-2011P in participants with POAG. Assessments of retinal images will be conducted by centrally masked assessors.
Participants will be admitted to the study site where eye examination and retinal imaging will be conducted before administration of the study drug. AMDX-2011P will be administered through a single IV bolus injection followed by safety assessments, retinal imaging, and blood collection and PK.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- AMDX-2011P
- Keywords
- POAG
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMDX-2011PDrug
AMDX-2011P single bolus injection intravenous for diagnostic review
| Study group | Role | What they receive |
|---|---|---|
| AMDX-2011P 50 mg | Experimental | AMDX2011P mg 50 (2ml) single bolus injection intravenous for diagnostic review Receives: Drug: AMDX-2011P |
| AMDX-2011P 100 mg | Experimental | AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review Receives: Drug: AMDX-2011P |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMDX-2011P Adverse Events Profile
Incidence, nature and severity of AEs/SAEs
Measured: 8 days
Secondary outcomes (3)
Concentration of AMDX-2011P
Plasma PK Concentration (CMax)
Measured: 2 hours
Pharmacokinetic Analysis of AMDX-2011P
Area under the plasma versus time curve (AUC)
Measured: 2 hours
Biological Activity
Detection of amyloid deposits in the retina after intravenous AMDX-2011P administration using a conventional retinal fundus fluorescence imaging device.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start7 Dec 2023
- Primary completionNov 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 2, randomized, parallel arm, open-label, masked endpoint study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amydis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Bingaman, Study director, Amydis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223048
- Sponsor's protocol ID
- AMDX-2011P-202
- Status last verified
- Jul 2024
- First submitted
- 14 Dec 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open Label Study of AMDX-2011P as a Retinal Tracer in Participants With Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT06223048
- Acronym / sponsor ID
- AMDX-2011P-202
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- POAG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Amydis Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to assess the ability of AMDX- 2011P to identify amyloid deposits in the retina of participants with Primary Open Angle Glaucoma (POAG).
Detailed description
This open-label, masked endpoint assessment study will evaluate safety, tolerability, plasma pharmacokinetics (PK) and biological activity of intravenous (IV) doses of AMDX-2011P in participants with POAG. Assessments of retinal images will be conducted by centrally masked assessors.
Participants will be admitted to the study site where eye examination and retinal imaging will be conducted before administration of the study drug. AMDX-2011P will be administered through a single IV bolus injection followed by safety assessments, retinal imaging, and blood collection and PK.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Phase 2, randomized, parallel arm, open-label, masked endpoint study
| Arm | Type | Receives |
|---|---|---|
| AMDX-2011P 50 mg | Experimental | Drug: AMDX-2011PAMDX2011P mg 50 (2ml) single bolus injection intravenous for diagnostic review |
| AMDX-2011P 100 mg | Experimental | Drug: AMDX-2011PAMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of primary open angle glaucoma in both eyes
- Able to fixate
- Glaucomatous optic nerve damage in both eyes, as determined by an investigator as part of an eye exam
Key exclusion criteria (3 listed)
- Participants unable to read or write
- Ocular media is not sufficiently clear to obtain acceptable quality images
- Participants with presence of any ocular pathology other than glaucoma in the study eye (cataracts are acceptable)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMDX-2011PAMDX-2011P single bolus injection intravenous for diagnostic review | Drug | AMDX-2011P 100 mg, AMDX-2011P 50 mg |
Primary outcome
AMDX-2011P Adverse Events Profile
Time frame: 8 days
Incidence, nature and severity of AEs/SAEs
3 secondary outcomes
Concentration of AMDX-2011P
Time frame: 2 hours
Pharmacokinetic Analysis of AMDX-2011P
Time frame: 2 hours
Biological Activity
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Primary Open Angle Glaucoma
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Bingaman contact
David Bingaman study director
Amydis Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMDX-2011P in people with Primary Open Angle Glaucoma, run by Amydis Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joyce Simpauco (858-254-7435, joyce@amydis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMDX-2011P Adverse Events Profile (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.